DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: PEG-IFN and entecavir (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Chulalongkorn University

Official(s) and/or principal investigator(s):
Pisit Tangkijvanich, M.D., Principal Investigator, Affiliation: Chulalongkorn University

Overall contact:
Pisit Tangkijvanich, M.D., Phone: +662-256-4482, Email: pisittkvn@yahoo.com

Summary

The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy

Clinical Details

Official title: A Randomized Design Study to Compare the Efficacy of Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B: Role of Host and Viral Factors Associated With Treatment Response

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B

Secondary outcome: To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women 18 to 65 years of age

- Patients with HBeAg-negative chronic hepatitis B

- Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg

- Serum HBV DNA levels ≥ 2,000 IU/mL at screening

- Increased alanine aminotransferase (ALT) levels [greater than the upper limit of

normal (ULN) and less than 10xULN}

- No signs or symptoms of advanced liver disease

- Patient has had a liver biopsy within 1 year of screening

Exclusion Criteria:

- Patient had previous treatment with IFN, peg-IFN, and/or entecavir

- Patient has evidence or history of chronic hepatitis not caused by HBV, including but

not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis

- Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus

- Patients with liver cancer

- Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of

childbearing potential throughout treatment.

- Patient has any other condition that is contraindicated for treatment with PEG-IFN or

entecavir

- Patient has any condition or pre-study laboratory abnormality, or history of any

illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug

Locations and Contacts

Pisit Tangkijvanich, M.D., Phone: +662-256-4482, Email: pisittkvn@yahoo.com

Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand; Recruiting
Pisit Tangkijvanich, M.D., Phone: +662-256-4482, Email: pisittkvn@yahoo.com
Pisit Tangkijvanich, M.D., Principal Investigator
Additional Information

Starting date: March 2011
Last updated: June 26, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017